CRA (Level I)
Core
Conduct remote or on-site clinical monitoring and site management to ensure protocol and regulatory compliance, manage documentation, and guarantee subject rights and data reliability.
Role type
Junior Clinical Research Associate (IC)
Builds
Clinical trials for pharmaceutical and biotech sponsors
Domain
Life Sciences / Clinical Research
Required skills
Risk-based monitoring, Root cause analysis, Protocol compliance, ICH-GCP guidelines, Site initiation, Data review (SDR/SDV/CRF), Investigational product inventory, Regulatory audit response
Preferred skills
Medical terminology, Clinical trial management systems, Process improvement
Technologies
Clinical Trial Management Systems, Microsoft Office
Responsibilities
Monitor investigator sites using risk-based approaches to identify failures and ensure compliance; Conduct on-site and remote monitoring activities including data review and product inventory; Initiate clinical trial sites and perform trial close-out; Ensure essential documents are complete per ICH-GCP; Provide trial status tracking and progress reports; Respond to regulatory requirements and audits; Manage administrative tasks like expense reports.
Seniority
Junior, entry-level IC